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| ID | Type | Description | Link |
|---|---|---|---|
| R21DK097476-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The investigators will examine in two studies whether citric acid or potassium citrate can reduce calcium phosphate saturation in urine of Calcium Phosphate stone formers.
We will examine in two short-term placebo-controlled cross-over metabolic studies whether citric acid or potassium citrate can reduce calcium phosphate saturation in urine of CaP stone formers.
The first study will be conducted in hypocitraturic CaP stone formers without hypercalciuria, and will compare the effects of potassium citrate, citric acid and placebo.
The second study will be conducted in hypercalciuric CaP stone formers on a thiazide diuretic who require potassium supplementation, and will compare the effects of potassium chloride alone, potassium chloride + citric acid, and potassium citrate alone. Physicochemical assays will be applied in addition to computer-based stone risk prediction programs to assess risk of stone recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo, then Citric Acid, then Potassium Citrate | Experimental | Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week) |
|
| Placebo, then Potassium Citrate, then Citric Acid | Experimental | Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week) |
|
| Potassium Citrate, then Placebo, then Citric Acid | Experimental | Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week) |
|
| Potassium Citrate, then Citric Acid, then Placebo | Experimental | Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | 3 tablets twice daily of matching placebo during the placebo phase. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Calcium Phosphate Saturation | This variable represents a ratio of the calcium phosphate saturation in a given urine sample to the calcium phosphate saturation at the point of precipitation and hence this measure has no units. | 2 weeks |
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Inclusion Criteria:
Aim 1
Aim 2
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| Name | Affiliation | Role |
|---|---|---|
| Naim M Maalouf, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75390-8885 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30036516 | Background | Doizi S, Poindexter JR, Pearle MS, Blanco F, Moe OW, Sakhaee K, Maalouf NM. Impact of Potassium Citrate vs Citric Acid on Urinary Stone Risk in Calcium Phosphate Stone Formers. J Urol. 2018 Dec;200(6):1278-1284. doi: 10.1016/j.juro.2018.07.039. Epub 2018 Jul 20. |
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Out of 41 patients who met inclusion criteria and were contacted for study enrollment, a total of 13 subjects agreed to enroll and were consented and each participant was evaluated during 3 phases in randomized order.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo, Then Citric Acid, Then Potassium Citrate | Placebo: 3 tablets twice daily of matching placebo during the placebo phase. Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day) Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day) |
| FG001 | Placebo, Then Potassium Citrate, Then Citric Acid | Placebo: 3 tablets twice daily of matching placebo during the placebo phase. Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day) Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day) |
| FG002 | Potassium Citrate, Then Placebo, Then Citric Acid | Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day) Placebo: 3 tablets twice daily of matching placebo during the placebo phase. Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day) |
| FG003 | Potassium Citrate, Then Citric Acid, Then Placebo | Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day) Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day) Placebo: 3 tablets twice daily of matching placebo during the placebo phase. |
| FG004 | Citric Acid, Then Potassium Citrate, Then Placebo | Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day) Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day) Placebo: 3 tablets twice daily of matching placebo during the placebo phase. |
| FG005 | Citric Acid, Then Placebo, Then Potassium Citrate | Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day) Placebo: 3 tablets twice daily of matching placebo during the placebo phase. Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Week) |
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| Washout (1 Week) |
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| Second Intervention (1 Week) |
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| Washout (1 Week) |
| |||||||||||||
| Third Intervention (1 Week) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo, Then Citric Acid, Then Potassium Citrate | Placebo: 3 tablets twice daily of matching placebo during the placebo phase. Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day) Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Urinary Calcium Phosphate Saturation | This variable represents a ratio of the calcium phosphate saturation in a given urine sample to the calcium phosphate saturation at the point of precipitation and hence this measure has no units. | Posted | Mean | Standard Deviation | no units | 2 weeks |
|
5 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo tablets twice daily Placebo: Matching placebo for both aims. |
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The second study (in hypercalciuric Cap stone formers) was never conducted due to difficulties in recruitment and limited budget.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Naim Maalouf | UT Southwestern Medical Center | 214/648-2954 | naim.maalouf@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 21, 2018 | Jan 22, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 23, 2018 | Jan 22, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| D007669 | Kidney Calculi |
| D053565 | Hypercalciuria |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D019343 | Citric Acid |
| D019357 | Potassium Citrate |
| ID | Term |
|---|---|
| D002951 | Citrates |
| D014233 | Tricarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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|
| Citric Acid, then Potassium Citrate, then Placebo | Experimental | Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week) |
|
| Citric Acid, then Placebo, then Potassium Citrate | Experimental | Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week) |
|
| Citric Acid | Dietary Supplement | 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day) |
|
| Potassium Citrate | Dietary Supplement | 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day) |
|
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 |
| Placebo, Then Potassium Citrate, Then Citric Acid |
Placebo: 3 tablets twice daily of matching placebo during the placebo phase. Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day) Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day) |
| BG002 | Potassium Citrate, Then Placebo, Then Citric Acid | Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day) Placebo: 3 tablets twice daily of matching placebo during the placebo phase. Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day) |
| BG003 | Potassium Citrate, Then Citric Acid, Then Placebo | Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day) Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day) Placebo: 3 tablets twice daily of matching placebo during the placebo phase. |
| BG004 | Citric Acid, Then Potassium Citrate, Then Placebo | Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day) Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day) Placebo: 3 tablets twice daily of matching placebo during the placebo phase. |
| BG005 | Citric Acid, Then Placebo, Then Potassium Citrate | Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day) Placebo: 3 tablets twice daily of matching placebo during the placebo phase. Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day) |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
|
| Height | Mean | Standard Deviation | metres |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
Potassium Citrate tablets twice daily
Potassium Citrate
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Citric Acid | Citric acid tablets twice daily Citric Acid | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | Potassium Citrate | Potassium Citrate tablets twice daily Potassium Citrate | 0 | 13 | 0 | 13 | 0 | 13 |
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| D052801 | Male Urogenital Diseases |
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014545 | Urinary Calculi |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D009930 |
| Organic Chemicals |